CIBO-P for pts with poor prognostic refractory or multiple disease recurrent aggressive NHL

Aim: To assess the activity and safety of a novel combination therapy for patients with recurrent or refractory aggressive NHL, to evaluate the long-term results, and identify prognostic factors in the study cohort.

Conclusions: In the current study, CIBO-P was a novel, highly active, and safe combination therapy for patients with refractory disease with a poor prognosis or for patients with multiply recurrent aggressive NHL.

Official Title

Lomustine (chloroethylnitrosourea [CCNU]), ifosfamide, bleomycin, vincristine, and cisplatin (CIBO-P) as an effective regimen for patients with poor prognostic refractory or multiple disease recurrent aggressive non-Hodgkin lymphoma

Conditions

Study Type

Prospective phase II

Study Design

Treatment: CIBO-PCCNU 60 mg/m2 i.v. d1Ifosfamide 1500 mg/m2 i.v. d1, 2, 21, 22 with mesnaBleomycin 5 mg/m2 i.v. d1, 5, 21, 25Vincristine 1.4 mg/m2 i.v. d1, 8, 21, 28Cisplatin 25 mg/m2 i.v. d3, 4, 5, 23, 24, 25Every 6 weeks (in responders 2 cycles after documentation of maximal response, but not < 3 cycles)

Further Details

Efficacy:OR: 77%CR: 19 (49%)PR: 11 (28%)MDR: 6 moMDS: 10.7 moTolerability:Anemia gr3- 25.5% Leukopenia gr3- 33%, gr4- 28%Neutropenia gr3- 42%, gr4- 28%Thrombocytopenia gr3- 44%, gr4- 7%Nausea/emesis gr3- 2.5%Diarrhea gr3- 2.5%Liver gr3- 9%Neuropathy gr3- 28%

Study Start

Eligibility & Criteria

Indication: Recurrent or refractory aggressive non-Hodgkin lymphoma (NHL).Eligibility: Histologically proven aggressive NHL; recurrence after previous chemotherapy or resistance to previous chemotherapy; WHO PS ≤ 3; no previous therapy with CCNU, ifosfamide or cisplatin; age > 18 years; no previous high-dose chemotherapy with autologous or allogeneic transplantation; normal bone marrow, liver and renal function.

Total Enrolment

43 (39 evaluable) 77% DLBCL, 11% anaplastic large cell, 12% T-cell lymphoma.

Contact Details

Musolino,A.; Perrone,M.A.; Michiara,M.; Delnevo,D.; Franciosi,V.; Di Blasio,B.; Ceci,G.; Camisa,R.; Ardizzoni,A.; Cocconi,G.Institution: University Hospital of Parma, Parma, Italy TypeCancer 103 (2005): 2109-2117